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Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM) (FREEDOM)

Primary Purpose

Venous Leg Ulcer

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Compression bandage

About this trial

This is an interventional treatment trial for Venous Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.8 and ≤ 1.3),
Wound in granulation phase (granulation tissue ≥50%),
Wound at least 3 cm away from any edge of another wound,
VLU between 2 and 20 cm2 in surface area,
VLU duration between 1 to 24 months.

Exclusion Criteria:

Patient under guardianship or protection of vulnerable adult,
Patient with known allergy to any components of the tested compression system,
Patient with a severe illness that might lead to premature discontinuation of the trial before the end of treatment period,
Patient with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immune suppressor,
Patient with non-controlled systemic infection by a suitable antibiotic therapy,
Patient who had a deep vein thrombosis within 3 months prior to the inclusion,
Patient with a lymphedema due to lymphatic obstruction,
Diabetic patient with advanced diagnosed microangiopathy,
Bedridden patient, or those spending less than one hour per day on their feet,
Wound covered partially or totally with necrotic tissue,
Clinically infected wound,
Wound requiring surgical treatment or for which a surgery is scheduled during the study period,
Cancerous lesions.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

URGOBD001

Arm Description

Compression bandage

Outcomes

Primary Outcome Measures

Relative reduction in wound surface area (percent)

Evolution between D0 and the 6 weeks treatment period with the URGO BD001 compression system: Relative reduction in wound surface area (%) = [(SW6 - SD0)/SD0] × 100 SD0: Wound surface area at D0 SW6: Wound surface area at Week 6

Secondary Outcome Measures

Complete ulcer closure:

The percent (%) of patients with complete ulcer closure (100% re-epithelialization) after 6 weeks or at the latest treatment period

Venous oedema

Oedema reduction from baseline (D0) and last assessment by measuring the limb circumference (in cm), using a tape: Ankle circumference at the reference point B (smallest perimeter of the leg, 3 cm above medial malleolus, Calf circumference at the reference point C (maximum perimeter of the calf).

Patient quality of Life (EuroQoL 5D-5L)

EuroQoL 5D-5L between baseline and at last visit. The questionnaire essentially consists of a descriptive system including 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a visual analogue scale (EQ VAS) from "the worst health you can imagine" (0) to "the best health you can imagine" (100).

Evolution of the periwound skin

Evolution of the peri-wound skin at each visit according to the following parameters: Healthy Altered: Erythematous and/or squamous (irritated dermatitis/eczema), maceration, other

Safety analysis

Nature and number of adverse event related to the use of the testing compression system (serious/ non-serious)

Full Information

NCT ID

NCT04613687

First Posted

October 20, 2020

Last Updated

November 2, 2020

Sponsor

Laboratoires URGO

1. Study Identification

Unique Protocol Identification Number

NCT04613687

Brief Title

Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM)

Acronym

FREEDOM

Official Title

Evaluation of the Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of Venous or Mixed Predominantly Venous Leg Ulcers

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 30, 2020 (Anticipated)

Primary Completion Date

September 30, 2021 (Anticipated)

Study Completion Date

September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratoires URGO

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to evaluate the therapeutic efficacy and the safety of the new compression system URGO BD001 in the management of venous or mixed predominantly venous leg ulcers. The therapeutic efficacy will be the reduction in wound surface area during a six weeks study treatment period.

Detailed Description

The compression bandage URGO BD001 is indicated for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous oedema and lymphedema justifying strong compression. The pressure applied with the compression system URGO BD001 help to improve venous return and to reduce venous oedema. The expected clinical benefits from the compression system URGO BD001 in patient with a VLU are to increase healing rate and time to healing, and to improve patient quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Leg Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective, multi centre, non-comparative study

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

URGOBD001

Arm Type

Experimental

Arm Description

Compression bandage

Intervention Type

Device

Intervention Name(s)

Compression bandage

Intervention Description

Compression bandage URGO BD001 for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous

Primary Outcome Measure Information:

Title

Relative reduction in wound surface area (percent)

Description

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Complete ulcer closure:

Description

The percent (%) of patients with complete ulcer closure (100% re-epithelialization) after 6 weeks or at the latest treatment period

Time Frame

6 weeks or last assessment

Title

Venous oedema

Description

Time Frame

6 weeks or last assessment

Title

Patient quality of Life (EuroQoL 5D-5L)

Description

Time Frame

6 weeks or last assessment

Title

Evolution of the periwound skin

Description

Evolution of the peri-wound skin at each visit according to the following parameters: Healthy Altered: Erythematous and/or squamous (irritated dermatitis/eczema), maceration, other

Time Frame

6 weeks or last assessment

Title

Safety analysis

Description

Nature and number of adverse event related to the use of the testing compression system (serious/ non-serious)

Time Frame

6 weeks or last assessment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.8 and ≤ 1.3), Wound in granulation phase (granulation tissue ≥50%), Wound at least 3 cm away from any edge of another wound, VLU between 2 and 20 cm2 in surface area, VLU duration between 1 to 24 months. Exclusion Criteria: Patient under guardianship or protection of vulnerable adult, Patient with known allergy to any components of the tested compression system, Patient with a severe illness that might lead to premature discontinuation of the trial before the end of treatment period, Patient with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immune suppressor, Patient with non-controlled systemic infection by a suitable antibiotic therapy, Patient who had a deep vein thrombosis within 3 months prior to the inclusion, Patient with a lymphedema due to lymphatic obstruction, Diabetic patient with advanced diagnosed microangiopathy, Bedridden patient, or those spending less than one hour per day on their feet, Wound covered partially or totally with necrotic tissue, Clinically infected wound, Wound requiring surgical treatment or for which a surgery is scheduled during the study period, Cancerous lesions.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Batot Géraldine, PhD

Phone

+33 3 80 44 28 46

g.batot@fr.urgo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Tacca Olivier, PhD

Phone

+33 3 80 44 74 22

o.tacca@fr.urgo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Senet Patricia, MD

Organizational Affiliation

Vascular dermatologist, APHP, Paris, France

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dissemond Joachim, MD

Organizational Affiliation

Clinic for dermatology, Essen- Germany

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM)

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